White HD， Ohman EM， Lincoff AM， Bertrand ME， Colombo A， McLaurin BT， Cox DA， Pocock SJ， Ware JA， Manoukian SV， Lansky AJ， Mehran R， Moses JW， Stone GW.
Green Lane Cardiovascular Service， Auckland City Hospital， Auckland， New Zealand. HarveyW@adhb.govt.nz
Abstract
OBJECTIVES: This study was designed to determine the impact of bivalirudin on 1-year outcomes in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).
BACKGROUND: The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated that in moderate- and high-risk ACS patients undergoing PCI， bivalirudin alone compared to unfractionated heparin (UFH) or enoxaparin plus a glycoprotein (GP) IIb/IIIa inhibitor resulted in less major bleeding and similar ischemic outcomes at 30 days. The impact of bivalirudin on 1-year outcomes in ACS patients undergoing PCI is unknown.
METHODS: In the ACUITY trial， 13，819 patients were enrolled， and 7，789 (56.4%) patients had PCI. Composite ischemia (death， myocardial infarction， or unplanned revascularization) and mortality at 1 year were assessed.
RESULTS: Among patients undergoing PCI， 2，561， 2，609， and 2，619 were randomized to UFH or enoxaparin plus a GP IIb/IIIa inhibitor， bivalirudin plus a GP IIb/IIIa inhibitor， and bivalirudin monotherapy， respectively. At 1 year， there were no differences in composite ischemia (17.8% vs. 19.4% vs. 19.2%， p = NS) or mortality (3.2% vs. 3.3% vs. 3.1%， p = NS) among the 3 groups， respectively.
CONCLUSIONS: Bivalirudin compared with UFH or enoxaparin plus a GP IIb/IIIa inhibitor results in similar rates of composite ischemia and mortality at 1 year in moderate- and high-risk ACS patients undergoing PCI.
目的：本研究目的在于测定急性冠状动脉综合征（ACS）患者行PCI术时使用比伐卢定后1年内对结果的影响。
背景：ACUITY（急性导管术和急诊介入治疗筛选策略）试验表明，在中等和高风险的ACS的患者行PCI术时，单独使用比伐卢定相比普通肝素或依诺肝素另加GPIIb/IIIa受体拮抗剂，结果导致在30天内主要出血减少及类似缺血的结果。ACS 患者行PCI术时使用比伐卢定后1年内对结果的影响仍然未知。
方法：在ACUITY试验中，共有13，819位患者参加，其中7，789(56.4%)名患者接受过PCI手术。对复合缺血（死亡，心肌梗死，或无计划的心肌血运重建术）和死亡率在一年内进行了评估。
结果：在所有接受PCI手术的患者中，2，561， 2，609， 和 2，619位患者随机分别接受普通肝素或依诺肝素加糖蛋白IIb/IIIa受体拮抗剂；比伐卢定加糖蛋白IIb/IIIa受体拮抗剂；单用比伐卢定治疗。1年内，3组间分别在复合缺血（ 17.8 ％比19.4 ％比19.2 ％， P = NS ）或死亡率（ 3.2 ％比3.3 ％ 比3.1 ％ ，P = NS）没有区别。
结论：对中到高度危险的ACS病人行PCI术时，比伐卢定与普通肝素或依诺肝素加糖蛋白IIb/IIIa受体拮抗剂治疗比较对混合缺血和主死亡率在1年内的影响类似。